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JOURNEY II XR Safety and Effectiveness PMCF

StatusActive, Not Recruiting
PhaseNot specified
Started
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Record History

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  1. 4 versions Re-verified since Sep 13, 2022, no change to tracked fieldsv11-v14
  2. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 174 to confirmed 176
    • Study sites: 12 to 14
    v10
  3. Site details revised at 3 of 12 sites
    • Eligibility criteria shortened, about 5 words
    v9
  4. Site details revised at 1 of 12 sitesv8
  5. Phase: Not applicable to Not specifiedv7
Show 5 earlier versionsHide 5 earlier versions
  1. Study sites: 4 to 12v6
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 3 to 4
    • Start date changed from estimate of Aug 2017 to Jul 28, 2017
    • Collaborators shortened, about 1 word
    v5
  3. Start date: Jul 2017 to Aug 2017v4
  4. Start date: Jun 2017 to Jul 2017v3
  5. Start date: May 2017 to Jun 2017v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study was designed to demonstrate the safety and performance of the JOURNEY II XR total knee system by evaluating implant survival rates at 10 years using Kaplan-Meier analysis. All participants will be implanted with the JOURNEY II XR total knee system.
Trial Details
NCT Number NCT03136887
Lead Sponsor Smith & Nephew, Inc.
Conditions
(from sponsor)		 Rheumatoid Vasculitis With Rheumatoid Arthritis of Knee, Unilateral Post-Traumatic Osteoarthritis of Knee, Knee Osteoarthritis, Degenerative Arthritis Peripheral Joint, Failed Osteotomies, Failed Unicompartmental Replacement
Related terms Osteoarthritis, Knee
Enrollment 176 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov